Kornimate/medical-research-clean huggingface dataset:
personalised risk-based breast cancer prevention and screening

Conditions: Breast Cancer

Summary: this is a cohort study, applied research and t3 translational genomics to estimate the impact of genetic risk for breast cancer detection in the screening program. the study group base consists of 28 389 female participants, currently in the age-group 22-79, in the biobank of estonian genome centre. the study is aimed to demonstrate the usability of personalised approach for adjusting and stratifying screening recommendations, based on predicted genetic risk estimates for breast cancer in the situation, where the genome data could be available from all women who have given informed consent for that. the project includes both the detection of moderate and high hereditary breast cancer risk carriers as well as high risk polygenic risk-score (consisting several single nucleotide polymorphisms) carriers among healthy individuals for application of personalised prevention and screening strategies.


Eligibility criteria:
inclusion criteria: cohort 1: * available ngs (wgs or wes) data for detection of breast cancer moderate to high genetic risk variants in brca1, brca2, tp53, stk11, pten, cdh1, atm, palb2, chek2, nbn, nf1 genes; * available genetic (wgs, genotyping) data for prs calculation, participants in age 40-74 will be further selected; cohort 2: * available genotyping data; * no available ngs data for brca1, brca2, tp53, stk11, pten, cdh1, atm, palb2, chek2, nbn, nf1 genes; * participants in the age group 40-74 with available genetic data for prs calculation; cohort stmg: • female participants in estonian biobank in the age group 50-69 participating at least once in the current estonian population-based screening program during 2016-2020. exclusion criteria: cohort 1: breast cancer in the medical history; cohort 2: breast cancer in the medical history. cohort stmg: none.

Keywords: breast cancer screening genetic risk polygenic risk score
behavioral economics incentives for health management

Conditions: Type 2 Diabetes; Obesity

Summary: incentives are increasingly being used to motivate health behavior in medical studies. small cash payments conditional on certain health and welfare promoting behaviors have shown efficacy in both real world and experimental settings. furthermore, in incentive studies, behavioral economics has been shown to amplify behavior change beyond what is possible with simple cash payments, but little is known about how varying incentive payment design may impact health behavior. the goal of the present study is to evaluate a new incentive payment instrument, lottery insurance, to determine its impact on adherence to the target health behavior, attendance at free exercise classes provided by queenscare family clinics, a safety-net medical clinic.


Eligibility criteria:
inclusion criteria: * 18 to 64 years of age * bmi between 25-40 * receiving care in queenscare family clinics exclusion criteria: * failure to obtain exercise clearance from physician

Keywords: behavioral economics incentives health behavior exercise
role of nefopam in rituximab transfusion reaction

Conditions: Nefopam

Summary: the patients will be taken nefopam ampule 50 mg before rituximab in the first group while the second group will be taken diphenhydramine ampule 10 mg before rituximab in the second group

the two groups will be taken standard therapy (hydrocortisone vial 100 mg and acetaminophen 1000 mg) 30 min before rituximab

Eligibility criteria:
inclusion criteria: * 18 - 80 years old male and female will be taken rituximab exclusion criteria: * less than 18 years old more than 80 years old diabetic patients
a pilot investigation of ciclesonide when administered as a hypotonic versus an isotonic formulation of ciclesonide nasal spray

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to measure the amount of a nasal steroid spray (ciclesonide) absorbed by the tissue in the nose 2 hours after having this study drug sprayed in the nose


Eligibility criteria:
inclusion criteria: 1. males and females 18 years of age or older. 2. history of perennial allergic rhinitis for at least 1 year prior to screening. 3. positive skin test to perennial allergen. exclusion criteria: 1. physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. 2. pregnant or lactating women. 3. upper respiratory infection within 14 days of study start. 4. active asthma requiring treatment with inhaled or systemic steroids. 5. use of any form of nasal spray during the previous month.
comparison of endoscopic injection of conventional and double doses cyanoacrylate for gastric variceal hemorrhage

Conditions: Gastric Variceal Bleeding

Summary: the recent practice guideline recommends endoscopic injection of cyanoacrylate (gvo) is the preferred method to treat acute gastric variceal bleeding. the rebleeding rate remains high following gvo.we hypothesized that a double-dose of cyanoacrylate may obliterate the varices more effectively and achieve better hemostasis.

although outcome of variceal hemorrhage has been improved in the last two decades, variceal hemorrhage is still the most serious complication of portal hypertension and chronic liver disease. occurrence of gastric varices (gv) rupture is less often than esophageal varices (ev) but it is characteristic of higher rebleeding rate and mortality and represents an even tougher problem than ev hemorrhage. facing these challenges, there is no consensus on the best treatment of gv hemorrhage and therefore it is mainly empirical. endoscopic treatment is an alternative in the management of gvh. injection sclerotherapy has been applied to arrest gv hemorrhage but it is associated with a high rebleeding rate (50\~90%) and thus is regarded as only a temporary hemostatic measure. the advantage of endoscopic variceal ligation for ev hemorrhage has been documented, however, endoscopic variceal ligation for gvh is not as promising because of its high rebleeding rate around 50%. endoscopic injection of n-butyl-2-cyanoacrylate, a so-called "tissue glue", was more effective for gv hemorrhage than other sclerosants and endoscopic ligation, however, its rebleeding rate is still high around 30\~50%. the theoretical advantages of tissue glue derives from its unique ability to plug the varix lumen immediately. each injection of tissue glue in conventional use was usually prepared by a mixture of 0.5 ml cyanoacrylate and 0.5 ml lipiodol. therefore, we hypothesized that double dose cyanoacrylate (1 ml cyanoacrylate mixed with 1 ml lipiodal) may obliterate the varices in further distance and broader area and that may achieve more effective hemostatic results than conventional dose. therefore we designed a randomized trial to test the hypothesis.

Eligibility criteria:
inclusion criteria: * patients with liver cirrhosis and/or hepatoma * aged 18 to 80, who had endoscopy-proven acute gvb * clinical signs of hematemesis, coffee ground vomitus, hematochezia, or melena * endoscopic signs of active bleeding from the gv * adherent blood clots, white nipple signs, or erosions on the gv * the presence of distinct large gv with red-color signs and absence of ev and other bleeding sources * who or their legally authorized representatives gave informed consent exclusion criteria: * patients had previous endoscopic, surgical treatment or transjugular intrahepatic portosystemic shunt (tips) for gvb * had a terminal illness of any major organ system, such as heart failure, uremia, chronic pulmonary disease, or non-hepatic malignancy.

Keywords: gastric variceal bleeding cyanoacrylate rebleeding complication survival acute gastric variceal bleeding
clinical manifestations and long-term outcome in early lyme neuroborreliosis

Conditions: Lyme Disease

Summary: in this retrospective cohort study of patients with early lyme neuroborreliosis (lnb), clinical and microbiologic characteristics and long-term outcome of definite vs. possible lnb were evaluated at a single university medical center in slovenia. severity of acute disease and long-term outcome during a 12-month follow-up were assessed using a composite clinical score based on objective clinical findings and subjective complaints.


Eligibility criteria:
inclusion criteria: * early lyme neuroborreliosis exclusion criteria: * not fulfilling study criteria for definite or possible lyme neuroborreliosis * alternative diagnosis during follow-up * concomitant tick-borne encephalitis * clinical symptoms/signs present for \>6 months * data not available

Keywords: lyme neuroborreliosis post-lyme borreliosis symptoms antibiotic therapy
lemaitre® cardial dialine ii post market study

Conditions: Vascular Aneurysm; Vascular Occlusive Disease; Artery Injury

Summary: this clinical study will capture clinical data specific to the performance and safety of the lemaitre® cardial dialine ii. it is a retrospective, monocenter, post-market safety and performance study. following the new mdr regulation, this study will allow the clinical data of the prosthesis to be completed in order to renew its ce marking.

the lemaitre cardial dialine® ii vascular prostheses (dialine ii) is a knitted pet (polyethylene terephthalate) graft manufactured with multifilament yarns and impregnated with bovine origin collagen to achieve a strong and dilatation resistant graft, which eliminates the preclotting step. the bovine collagen is then gradually resorbed by the patient. the dialine ii comes with black guide lines and crimped construction to facilitate implantation. other design features include: * thin wall design (0.50+/-0.12mm) with excellent conformability * special impregnation process for maximum leakage resistance * water permeability \< 10 ml/cm2/min the dialine ii is indicated for replacement or bypass procedures in aneurysmal and/or occlusive diseases of the abdominal aorta or peripheral arteries. the dialine ii is also indicated for arterial reconstruction in patients requiring systemic heparinization. the unique collagen impregnation results in exceptional resistance to leakage, even under systemic heparinization.

Eligibility criteria:
inclusion criteria: * male and female subjects, ≥ 18 years of age * subject who has undergone surgical treatment for the replacement or bypass in aneurysmal and/or occlusive diseases and for arterial reconstruction in patients requiring systemic heparinization with lemaitre cardial dialine ii (between 01jan2010 and 31jul2016). exclusion criteria: * co-morbidity that in the discretion of the investigator might confound the results. * patient operated on with a dialine ii vascular prosthesis in conditions where it is connected with another one and that will make impossible to attribute the complication in the case it occurs * infection that may affect the safety or the efficacity of the prothesis

Keywords: vascular prosthesis aneurysm occlusion arterial reconstruction
impact of prebiotics in ulcerative colitis

Conditions: Crohn Disease; Ulcerative Colitis

Summary: the cause of inflammatory bowel disease (ibd) is currently unknown, although partly attributed to interactions among genetic risk polymorphisms, environmental factors, gut microbiome, and host immunity. diet, particularly those with plant-based products, have been shown in prior research to improve gut microbial composition, which has been linked to different ibd-related outcomes. this study is interested in evaluating the impact of prebiotics on gut microbiome composition and gut health in patients with ibd. dietary composition will be assessed at baseline and over the course of 16 weeks. participants will be randomized to either consume an 8-week course of prebiotic supplementation beginning at week 0 or week 8. stool samples will be collected at weeks 0 and 8. the stool will be analyzed for cross-sectional and longitudinal fecal microbial changes associated with different prebiotic and diet consumption patterns in the context of heterogeneous disease characteristics.


Eligibility criteria:
inclusion criteria: * ages 18 to 85 years old * history of biopsy-proven ulcerative colitis (uc) * active symptoms (sccai \>2) * concomitant use of 5-aminosalicylates, immunomodulators, and corticosteroids will be permitted, although initiation or dose adjustment must not have occurred within 30 days prior to enrollment. * concomitant use of biologic therapy will be permitted, although initiation or dose adjustment must not have occurred within 60 days prior to enrollment. * prior probiotics or other dietary supplements use is permitted but will be asked to be discontinued during the course of the trial exclusion criteria: * prior colectomy * hospitalization * urgent need for abdominal surgery * unstable major medical condition * active malignancy under treatment * active alcohol or non-cannabinoid substance abuse * pregnancy or lactation * concerns for non-compliance
predictive factors of survival with and without repetition with 5 and 10 years curative post-oesophagectomy for cancer of the oesophagus

Conditions: Esophageal Cancer; Esophageal Surgery Cancer; Overall Survival

Summary: prospective study of predictive factors of survival with and without repetition with 5 and 10 years curative post-oesophagectomy for cancer of the oesophagus


Eligibility criteria:
inclusion criteria: * patients undergoing during inclusion time carcinologic esophagectomy for esophageal cancer (adenocarcinoma or epidermoid carcinoma) exclusion criteria: mortality within 90 postoperative days -
trec-lebanon: a trial for rapid tranquilisation for agitated patients in the emergency setting

Conditions: Psychiatric Emergency; Aggression; Agitation

Summary: this is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department.

this is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department. around 10% of patients will present to the psychiatric emergency unit with a violent episode that requires rapid tranquilisation. surveys of practice and opinion has shown that variety of methods have been used and no universal option exists. this study will look at haloperidol plus promethazine versus haloperidol plus promethazine plus chlorpromazine in violent aggressive psychiatric patients.

Eligibility criteria:
inclusion criteria: * patient will be eligible if (1) requiring emergency acute intramuscular sedation because of disturbed and dangerous behaviour and (2) if the clinician is uncertain of the benefits between haloperidol plus promethazine vs haloperidol plus promethazine plus chlorpromazine. * gender - both male and female * age (18-64) * clinician is unaware on the effects of either treatment interventions exclusion criteria: * if the clinician knows one treatment has benefit over another for a particular person * if the clinician is aware of a contra-indication of one of the treatments * if there is an advanced directive expressing a wish for one or other, or another treatment in the emergency setting. * if the clinician does not want to undertake for both personal and professional reasons. * if the participant is known to be allergic to one or more of the interventions * already randomized * already sedated * accompanying person (friend/family/police officer) refuses patient trial entry
daily chlorhexidine care at the exit site in peritoneal dialysis patients

Conditions: Peritoneal Dialysis Catheter Exit Site Infection

Summary: chlorhexidine is used in central line dressing changes and is effective in reducing line infections. it is unclear if daily chlorhexidine care at the exit site in peritoneal dialysis (pd) patients can reduce the risk of staphylococcus aureus (sa) colonization or exit site infection.

there is no consensus on what regimen is optimal for topical care of the peritoneal dialysis (pd) catheter exit site. several methods including soap and water, povidone-iodine, hydrogen peroxide, chlorhexidine, and topical antimicrobial agents such as gentamicin or mupirocin cream have been described for care of the exit site. however, many of these studies were small or short-term and lacked longitudinal evaluation of bacterial decolonization efficacy. staphylococcus aureus (sa) is one of most common causes of peritonitis and exit-site infection and is associated with a high pd catheter removal rate. carriers of sa had a higher rate of exit-site infection than non-carriers. in previous studies, staphylococcal carriage prophylaxis using either mupirocin or gentimicin ointment in the nares or exit site significantly reduced the rate of exit-site infection due to sa. however, emerging antibiotic resistance is a concern. in addition, mrsa infection in pd patients is more severe than other pathogens; therefore, choosing a good antiseptic for sa and/or mrsa decolonization is important. in recent years, the use of chlorhexidine in bathing or central line dressing changes was implemented to prevent bacterial colonization and multidrug resistant bacterial infections and was also used in hemodialysis patients. data regarding chlorhexidine used in the catheter care of pd patients are limited and it is unclear if the use of chlorhexidine for exit site care contributes to long-term bacterial decolonization and acts as a prophylaxis for exit site infections.

Eligibility criteria:
inclusion criteria: * patients \> 20 years old who received pd for more than 3 months exclusion criteria: * a history of psychological illness or condition that interferes with caring of a wound * recent (within 1 month) exit-site infection, peritonitis, or tunnel infection * recent treatment with an antibiotic administered by any route in the last month * or known hypersensitivity to or intolerance of chlorhexidine or mupirocin
the effect of sodium bicarbonate (nephrotrans®) on calcification propensity of serum in kidney transplant recipients

Conditions: Kidney Transplant; Complications

Summary: this is a single-center, prospective, open-label, randomized, cross-over study.

the primary hypothesis (h1) is that the t50 value will change between wash-out and high-dose (3000mg/d) sodium bicarbonate (nephrotrans®) substitution. the 0-hypothesis (h0) is that substitution of 3000 mg/d sodium bicarbonate (nephrotrans®) has no effect on t50-values as compared to wash-out-phase. patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence a-b) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence b-a) with washout-phases in between. patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence a-b) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence b-a) with washout-phases in between. the study will start with an initial run-in wash-out phase, where all sodium bicarbonate or other alkalizing treatment taken by the patient as standard of care will be discontinued. consequently, there will be a sodium bicarbonate treatment (high dose/low dose) phase, followed by a wash-out phase, followed by another sodium bicarbonate treatment (high dose/low dose) phase, followed by a final wash-out phase. each study phase, including wash-out phases as well as low-dose and high-dose treatment phases will be 14 ±3 days of duration. patients will be followed up to 12weeks after randomization until the last study visit of the final wash-out phase.

Eligibility criteria:
inclusion criteria: * adults ≥ 18 years old * prevalent (≥ 6 months after kidney transplantation) kidney transplant recipients * egfr (ckd-epi formula) between 10 and 50 ml/min/1.73 m² * patient has provided informed consent prior to initiation of any study related procedure exclusion criteria: * allergy to sodium bicarbonate or any component of nephrotrans®, namely soy or peanuts (reported cross-reactivity to peanuts has been reported in patients with soy-allergy). * unstable clinical condition (e.g. uncontrolled heart failure, clinical uremia, uncontrolled hypertension, impending initiation of dialysis treatment...) as judged by the recruiting physician * pregnant and nursing (lactating) women * unwillingness to discontinue current medication with sodium bicarbonate * unwillingness to discontinue antacids containing aluminum, calcium carbonate, magnesium, lactate, citrate, bicarbonate or mixtures thereof
liquid biopsy, lung and colon cancer in andalucia

Conditions: Non Small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC)

Summary: the objective of the lola project is to analyse the impact of adopting xf liquid biopsy panel, in the real world of the andalusian health public system in terms of impact on clinical practice and cost through the assessment of clinical impact, duration of turnaround time (tat) of xf test vs standard of care and the analysis of resource utilisation.


Eligibility criteria:
inclusion criteria: general criteria: * more than 18 years old * both genders * ability to provide written informed consent specific criteria: * nsclc * patients diagnosed with the 8th edition of the tumor, node, metastasis (tnm) staging system for lung cancer approved by international association for the study of lung cancer (iaslc) and the american joint committee on cancer (ajcc): iv (any t, any n, m1a-c) * histologically confirmed nsclc (adenocarcinoma) * performance status of 0-2 (ecog ps) ○ estimated life expectancy ≥3 months * treatment naïve patients (chemotherapy, immunotherapy, targeted therapy, radiotherapy). * smokers or non-smokers * crc * patients diagnosed with the tumor, node, metastasis (tnm) staging system for colorectal cancer approved by the american joint committee on cancer (ajcc): iv (any t, any n, m1a-c) * histologically confirmed crc (adenocarcinoma) * performance status of 0-2 (ecog ps) * estimated life expectancy ≥3 months * treatment naïve patients (chemotherapy, immunotherapy, targeted therapy, radiotherapy). exclusion criteria: * general: history of any other cancer within the previous 5 years, except non-melanoma skin cancer * general: absence of informed consent. \> pregnant or nursing women. \> small cell lung cancer.

Keywords: liquid biopsy cfdna ctdna metastatic cancer ngs